Most people don’t understand that we have limited options to treat folks with the flu.

They still think that Tamiflu is some kind of wonder drug.

It isn’t. At best, if you take it within 48 hours of the start of your flu symptoms, you might “shorten the duration of fever and illness symptoms, and may reduce the risk of complications from influenza.”

What to Know About Xofluza for the Flu

That’s why many of us welcomed news of a new flu drug – Xofluza (baloxavir marboxil).

“This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option.”

Scott Gottlieb, M.D., FDA Commissioner

Unfortunately, while it has a new mechanism to treat the flu, there are plenty of reasons to not get too excited about Xofluza, despite what the headlines might be telling you:

the clinical benefit seems similar to Tamiflu

the two studies that were used to get Xofluza approved only looked at folks with mild to moderate flu symptoms (those with severe flu symptoms were excluded) and only looked at folks without complex medical problems, so we don’t know if it reduces hospitalizations, flu complications, or deaths from flu

flu virus strains might be able to mutate and develop resistance to Xofluza, although it is not clear if these strains could then be passed to others

the single dose treatment is only approved for adults and kids who are at least 12 years old

at $120 to $150, it is more expensive than generic Tamiflu

Still, if it works just as well as Tamiflu, but really does have fewer side effects, then that is a good thing, especially if it isn’t overused.

“The significant reduction in influenza viral replication with baloxavir treatment suggests the potential for reducing influenza virus spread to close contacts and should be studied through randomized, controlled trials in households and during institutional influenza outbreaks such as in longterm care facilities.”

Timothy M. Uyeki, M.D., M.P.H., M.P.P. on A Step Forward in the Treatment of Influenza

Could Xofluza make you less contagious to others?

That would be a good way to control outbreaks.

Why isn’t it approved for younger kids? The pediatric studies haven’t been completed yet, but among the postmarketing studies that the FDA are requiring are in infants, children between the ages of 12 months to less than 12 years, and the final report of a pediatric study from Japan.

Other postmarketing studies of Xofluza will include hospitalized patients, the use of Xofluza as post-exposure prophylaxis to prevent influenza in household contacts of an index case, and to monitor resistance.

Are you excited about Xofluza?

Should folks be excited about Xofluza? While it is certainly nice to have an alternative to Tamiflu, an alternative that worked a lot better would have really gotten most of us excited.

being inconsolable or so irritable that your child does not even want to be held

having chest pain

is suddenly dizzy

being confused

having seizures

having severe vomiting

You should also seek medical attention if your child was getting better, but then got worse again, especially if they again develop a fever and a worsening cough. Or if your child has a chronic health problem, like asthma or diabetes, and the flu is making it hard to control.

How will your child be treated? It depends, on treatments might include oxygen, IV fluids, antiviral medications, and antibiotics (if there is a secondary bacterial infection), etc.

And remember that children under the age of two to five years and those with chronic health conditions, such as asthma, diabetes, neurologic and neuromuscular conditions, and heart disease, etc., are most at risk for severe flu complications.

In four of the last deadliest flu seasons, at least half of the kids had no underlying medical conditions.

But you don’t have to be at high risk to develop flu complications.

Many of the kids who die with the flu each year don’t have any underlying health problems.

And at least half of the kids who die with flu complications are school age children and teens.

Anyone, even previously healthy kids, can develop pneumonia, myocarditis, encephalitis, or septic shock, etc., so get help if you see any of the above signs and symptoms that your child with the flu is getting worse.

And get your kids vaccinated. Tragically, most kids who die with the flu each year didn’t have a flu shot.

What to Know About the Warning Signs of a Severe Case of the Flu

Seek medical attention if your child’s flu symptoms are getting worse, especially if it seemed they were getting better, but then got worse again, which can all be signs of complications of a severe flu case.